The following data is part of a premarket notification filed by Intl. Mycoplasma/mdc Assoc. with the FDA for Serofast.
| Device ID | K903958 |
| 510k Number | K903958 |
| Device Name: | SEROFAST |
| Classification | Antisera, All Mycoplasma Spp. |
| Applicant | INTL. MYCOPLASMA/MDC ASSOC. P.O. BOX 641 Manchester, MA 01944 |
| Contact | Fran Griggs |
| Correspondent | Fran Griggs INTL. MYCOPLASMA/MDC ASSOC. P.O. BOX 641 Manchester, MA 01944 |
| Product Code | GSA |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1990-12-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SEROFAST 74217084 not registered Dead/Abandoned |
International Mycoplasma 1991-10-30 |